(85 days)
The device is to be used to remove fluids from the airway or respiratory support system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection tubing that is connection val. It is for use only on the order of a physician or other licensed practitioner (e.g. EMT-field use).
Plaxtron Suction Unit, Model 88AA51/88AA61 series. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister.
This is a 510(k) summary for a medical device called the Plaxtron Suction Unit. It describes the device, its classification, and its substantial equivalence to a predicate device. However, this document does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance.
510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device, often through a comparison of technological characteristics and performance data (which may include bench testing, animal studies, or clinical data, depending on the device). For non-AI/ML devices, this usually involves demonstrating that the new device performs as safely and effectively as the predicate, often by meeting recognized performance standards. This particular submission explicitly references ISO 10079-1:2009 for its recognized performance standard.
Therefore, many of the requested points related to AI/ML evaluation (like sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable to the provided document.
Here's what can be extracted and inferred from the provided text regarding the closest equivalent to "acceptance criteria" and "study" for this type of device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from ISO 10079-1:2009 for "Powered Suction Pump") | Reported Device Performance |
|---|---|
| General Safety and Performance Requirements of ISO 10079-1:2009 (This standard typically covers aspects like: maximum vacuum, flow rate, noise, electrical safety, electromagnetic compatibility, alarm functions, mechanical stability, durability under normal use, cleaning/disinfection properties, battery life/charging for portable units, materials compatibility, and instructions for use.) | While specific numerical performance metrics are not present in this 510(k) summary (they would typically be in the full submission, often in a comparison table with the predicate), the statement of "substantial equivalence" to the predicate device (DeVilbiss Suction Unit, Model 88 00 50 & 88 00 60, marketed as Laerdal Compact Suction Unit (LCSU 3)) and adherence to ISO 10079-1:2009 implies that the Plaxtron Suction Unit has demonstrated performance that is comparable to the predicate and meets the safety and performance requirements outlined in the referenced ISO standard. This comparison would have been presented to the FDA to establish substantial equivalence. |
| Functional Equivalence to Predicate Device (Implied by 510(k) process) | The device is intended for the same Indications for Use: "to remove fluids from the airway or respiratory support system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister." This functional equivalence underpins the substantial equivalence determination. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided in this summary. For a non-AI/ML device like this, "test set" would refer to the samples or units tested as part of bench testing to meet the ISO standard. This information is typically proprietary and detailed in the full 510(k) submission, not the public summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This document pertains to a physical medical device (suction pump), not an AI/ML diagnostic or predictive algorithm. Therefore, there is no "ground truth" in the AI/ML sense to be established by clinical experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This relates to AI/ML software for interpretation, not a physical suction pump.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This relates to AI/ML algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For this device, "ground truth" in functional testing would be adherence to the performance specifications of the referenced standard (ISO 10079-1:2009), verified through engineering and bench testing, rather than a clinical "ground truth" derived from patient data.
8. The sample size for the training set
- Not applicable. This relates to AI/ML algorithms.
9. How the ground truth for the training set was established
- Not applicable. This relates to AI/ML algorithms.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as inferred from a 510(k) for a non-AI/ML device):
The provided 510(k) summary indicates that the Plaxtron Suction Unit, Model 88AA51/88AA61 series, has demonstrated substantial equivalence to the predicate device, the DeVilbiss Suction Unit, Model 88 00 50 & 88 00 60 (also known as Laerdal Compact Suction Unit (LCSU 3)).
The primary "study" or evidence to support this substantial equivalence and thus meet performance expectations would have included:
- Bench Testing / Performance Testing: The device's performance characteristics (e.g., vacuum pressure, flow rate, safety features, durability, electrical characteristics) were tested against the requirements of the ISO 10079-1:2009 standard for "Powered Suction Pump." This standard sets the "acceptance criteria" for such devices. The full 510(k) submission would contain detailed reports of these tests, demonstrating that the Plaxtron unit passed all relevant sections of the standard.
- Comparison to Predicate Device: A detailed comparison of the technological characteristics (design, materials, energy source, performance specifications, intended use, etc.) of the Plaxtron Suction Unit to those of the predicate device was performed. The data from the Plaxtron unit's performance testing (against ISO 10079-1:2009) would have been used to show that its performance is equivalent or better than the predicate's, affirming it is as safe and effective.
The FDA's decision to grant 510(k) clearance (as indicated by the letter from Mark N. Melkerson) signifies that the agency reviewed this evidence and determined the device is substantially equivalent to a legally marketed predicate, meaning it meets the necessary safety and effectiveness requirements.
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PLAXTRON INDUSTRIAL (M) SDN. BHD.
APR - 3 2012
A107
510 (K) Summary
| 5.1 Device Trade Name: | Plaxtron Suction Unit, Model 88AA51/88AA61 series |
|---|---|
| 5.2 Named and Address ofManufacturer: | PLAXTRON INDUSTRIAL (M) SDN. BHD.plot 28, kawasan perusahaan, jelapang 2, ftz,ipoh, MALAYSIA 30020 |
| EstablishmentRegistration Number: | 8044169 |
| Contact Person: | Doris YangEngineering / Regulatory Affairs Manager |
| Or | |
| Leo ChienGeneral Manager | |
| Tel: 886-2-26892001Fax: 886-2-26892468E-mail: chtwn@ms21.hinet.net | |
| 5.3 Device ClassificationNames: | 1) apparatus, suction, ward use, portable, ac-powered |
| Regulation Description: | Powered Suction Pump |
| Review Panel: | General & Plastic Surgery, |
| Regulation Number: | §878.4780 |
| Classification: | Class II |
| Product Code: | 1) JCX |
| Recognized PerformanceStandard | ISO 10079-1:2009 (JCX) |
| 5.4 Predicate Devices: | (a) DeVilbiss Suction Unit. Model 88 00 50 & 88 00 60,marketed name: Laerdal Compact Suction Unit (LCSU3). 510(k) Number: K982304 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Plaxtron Industrial (M) SDN, BHD % Sen Mu Technology Co., Ltd Ming-Yie Jan, Ph.D. No.15-2. Lane 26, Mincyuan 15t Road Lingya District, Kaohsiung City Taiwan 802
Re: K120065
Trade/Device Name: Plaxtron Suction Unit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: JCX Dated: March 13, 2012 Received: March 21, 2012
Dear Dr. Ming-Yie Jan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
APR - 3 2012
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Page 2 - Ming- Yie Jan, Ph.D.
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set . forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor.You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for use
510(k) Number (if known): ___K120065
Device Name: Plaxtron Suction Unit
Indications for Use:
The device is to be used to remove fluids from the airway or respiratory support system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection tubing that is connection val. It is for use only on the order of a physician or other licensed practitioner (e.g. EMT-field use).
Prescription Use _X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard T. Fisher for Ned Oeylon
(Division Sign-Off)
(Division Sign-C)) Division of Surg. al. Orthopedic, and Restorative Jevices
510(k) Number_< 12 00G
Page __ of
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.